Stepped Care, Peer-Delivered Intervention to Improve ART Adherence and SUD in Primary Care

阶梯式护理、同伴提供的干预措施可提高初级护理中的 ART 依从性和 SUD

基本信息

批准号：
10675089
负责人：
Jessica F Magidson
金额：
$ 58.88万
依托单位：
UNIV OF MARYLAND, COLLEGE PARK
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-01 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10675089
关键词：
Address Adherence Adoption Affect Aftercare Attitude Behavior Therapy Behavioral Biological Markers Blood Caring Clinic Clinical Continuity of Patient Care Counseling Data Diabetes Mellitus Dose Dryness Effectiveness Epidemic Evidence based intervention Feedback HIV Health Health Care Sector Home Hybrids Hypertension Individual Intervention Interview Life Low income Measures Mental Depression Mental Health Services Mentored Patient-Oriented Research Career Development Award Methods Modeling National Institute of Drug Abuse Outcome Participant Patient Participation Patient Self-Report Patients Persons Pilot Projects Policy Maker Population Primary Care Problem Solving Provider Qualitative Research Randomized Reach, Effectiveness, Adoption, Implementation, and Maintenance Resource Allocation Resource-limited setting Resources Services Site South Africa Spottings Substance Use Disorder Testing Time Training Treatment outcome Urinalysis Viral Load result Work antiretroviral therapy cost effective cost estimate design economic impact economic value effectiveness outcome effectiveness testing effectiveness trial effectiveness-implementation randomized trial effectiveness/implementation hybrid effectiveness/implementation trial electronic adherence monitoring ethnic minority population high risk high risk population implementation measures implementation outcomes implementation strategy improved low and middle-income countries medication compliance mindfulness motivational enhancement therapy motivational intervention patient retention peer peer recovery phosphatidylethanol preference primary care services primary care setting primary outcome racial minority recruit reduced substance use relapse prevention response skills standard of care substance use substance use treatment success therapy adherence transmission process treatment program uptake willingness to pay

项目摘要

Significance: This proposal is for a type 2 hybrid effectiveness-implementation trial to test an intervention and implementation strategy of a peer-delivered, stepped care approach for integrating HIV and substance use (SU) services in a resource-limited primary care setting. Globally, a SU treatment gap exists, with only 1-4% of individuals who need treatment in the most resource-limited contexts receiving minimally adequate treatment. Given the impact of untreated SU on poor HIV outcomes along the care continuum, efforts are needed to sustainably integrate behavioral interventions into primary care settings to reach individuals at highest risk for poor ART adherence and SU outcomes. This gap in care in resource-limited settings will be met through implementing a peer-delivered, stepped care intervention, which has been successfully piloted in Cape Town, South Africa in the PI’s K23 award (“Khanya”). Preliminary work: Our team has developed and adapted the Khanya peer-delivered intervention based on key stakeholder feedback to improve ART adherence among PLWH with SU in primary care in South Africa. Khanya integrates Life-Steps, a single-session problem solving and motivational intervention for ART adherence, with brief behavioral skills to reduce SU (i.e., behavioral activation, mindfulness, relapse prevention). The PI’s K23 award included a pilot Type 1 hybrid effectiveness- implementation trial that demonstrated initial feasibility, acceptability, and preliminary effectiveness of Khanya for improving ART adherence compared to enhanced standard of care (ESOC). At post-treatment, adherence in Khanya was M=60.3% days vs. M=26.5% in ESOC. Methods: Guided by RE-AIM, the current study aims to test in a Type 2 hybrid effectiveness-implementation trial the effectiveness and implementation of a stepped- care Khanya intervention for PLWH at highest risk for ongoing ART nonadherence and HIV transmission. A stepped care approach is appealing in a resource-limited context, as the least resource intensive part of an intervention is delivered first, and only individuals who do not respond receive the more resource intensive part of the intervention. 150 PLWH with SU will be recruited from an integrated primary care site and randomized to ESOC (i.e., facilitated referral to public SU treatment) or Khanya. Khanya begins with Life-Steps + ESOC, and only those who continue to demonstrate ART nonadherence (i.e., detected using real-time electronic adherence monitoring; ≥3 missed doses in a 2-week period) will step up to receive the full intervention. Based on our pilot data, we anticipate Life-Steps + ESOC alone will be sufficient for ~44% of patients to overcome barriers to ART adherence, but the other ~56%, particularly those with more severe SU, will require the full intervention. Participants will be followed for 12 months on: ART adherence (Wisepill, DBS concentrations, and self-report), SU (urinalysis, PEth, and self-report), implementation (reach and uptake, fidelity, adoption), and economic impact. The overall aim is to test a feasible, sustainable, and effective peer-delivered approach to improve ART adherence among PLWH with SU in resource-constrained primary care settings.

意义：本提案旨在进行 2 类混合有效性实施试验，以测试干预措施和将艾滋病毒和药物滥用结合起来的同伴交付、阶梯式护理方法的实施策略在资源有限的初级保健环境中，SU 服务存在缺口，只有 1-4%。在资源最有限的情况下需要治疗的个人只能得到最低限度的充分治疗。鉴于未经治疗的 SU 对整个护理过程中艾滋病毒结果不佳的影响，需要努力将行为干预措施可持续地纳入初级保健机构，以覆盖感染风险最高的个人资源有限环境下 ART 依从性差和 SU 结果不佳的情况将通过以下方式弥补。实施同伴提供的阶梯式护理干预措施，该干预措施已在开普敦成功试点，南非获得 PI 的 K23 奖（“Khanya”）。初步工作：我们的团队已开发并调整了该奖。 Khanya 同行根据关键利益相关者的反馈进行干预，以提高 ART 的依从性南非的 PLWH 与 SU 在初级保健中整合了 Life-Steps，这是一种单次问题解决方案。以及对 ART 依从性的动机干预，通过简短的行为技能来减少 SU（即行为激活、正念、预防复发）PI 的 K23 奖包括试点 1 型混合有效性 - 实施试验证明了 Khanya 的初步可行性、可接受性和初步有效性与强化护理标准 (ESOC) 相比，提高 ART 依从性在治疗后，依从性。 Khanya 中的 M=60.3% 天数与 ESOC 中的 M=26.5% 方法：以 RE-AIM 为指导，当前研究旨在在 2 类混合有效性实施试验中测试逐步实施的有效性和实施情况对持续抗逆转录病毒疗法不依从和艾滋病毒传播风险最高的感染者进行护理 Khanya 干预 A。阶梯式护理方法在资源有限的情况下很有吸引力，因为它是一个资源密集程度最低的部分。首先进行干预，只有没有响应的个人才会收到资源密集的部分将从综合初级保健中心招募 150 名接受 SU 的 PLWH，并随机分组 ESOC（即促进转诊至公共 SU 治疗）或 Khanya 从 Life-Steps + ESOC 开始，并且只有那些继续表现出 ART 不依从性的人（即使用实时电子检测仪检测到依从性监测（两周内漏服 3 次以上）将加强接受全面干预。根据我们的试点数据，我们预计仅 Life-Steps + ESOC 就足以让约 44% 的患者克服困难 ART 依从性的障碍，但其他约 56%，特别是那些患有更严重 SU 的人，将需要充分的参与者将接受为期 12 个月的跟踪：ART 依从性（Wisepill、DBS 浓度和自我报告）、SU（尿液分析、PEth 和自我报告）、实施（影响范围和采用、保真度、采用）以及总体目标是测试一种可行、可持续和有效的同行交付方法。在资源有限的初级保健机构中通过 SU 提高 PLWH 的 ART 依从性。